FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
114961–114984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 1992
ACUFEX ENDOFIX BUTTON
K922559 · EBG
Acufex Microsurgical, Inc.
Dental · 209d
Cleared Dec 24, 1992
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
K923140 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Dec 24, 1992
QUADATURE HEAD/NECK/VASCULAR COIL
K923423 · LNH
Medical Advances, Inc.
Radiology · 164d
Cleared Dec 24, 1992
SHARPULSE
K923855 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 167d
Cleared Dec 24, 1992
IV-TUBE SECURE
K923882 · FPA
Ximedix, Inc.
General Hospital · 142d
Cleared Dec 24, 1992
HCG STAT-PAK
K923925 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Dec 24, 1992
TRANSYSTEM LIQUID AMIES MEDIUM
K924328 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 24, 1992
TRANSYSTEM AMIES W/O CHARCOAL
K924329 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 24, 1992
TRANSYSTEM AMIES WITH CHARCOAL
K924330 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 24, 1992
TRANSYSTEM LIQUID STUART MEDIUM
K924331 · LIO
Pro-Lab Diagnostics
Microbiology · 119d
Cleared Dec 24, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K924479 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Dec 24, 1992
MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL
K924653 · LNH
Mri Devices Corp.
Radiology · 100d
Cleared Dec 24, 1992
AUTOPOLE REGULATOR SYSTEM
K924999 · KYG
Escalon Trek Medical
Ophthalmic · 83d
Cleared Dec 24, 1992
ACUFEX CANNULATED BONE TUNNEL PLUGS
K925437 · HRX
Cufex Microsurgical, Inc.
Orthopedic · 57d
Cleared Dec 24, 1992
DISPOSABLE HAND-SWITCHING ESU PENCIL
K925619 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 48d
Cleared Dec 23, 1992
SENSOR SHIELD
K910811 · DQA
Medical Taping Systems, Inc.
Anesthesiology · 666d
Cleared Dec 23, 1992
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
K914823 · DXN
Omron Healthcare, Inc.
Cardiovascular · 425d
Cleared Dec 23, 1992
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573 · DTN
Baxter Healthcare Corp
Cardiovascular · 377d
Cleared Dec 23, 1992
NEW TOOTH MATERIAL
K920684 · ELM
Dentsply Intl.
Dental · 313d
Cleared Dec 23, 1992
THE KEYSTONE SYSTEM
K920877 · BZG
S & M Instrument Co.
Anesthesiology · 301d
Cleared Dec 23, 1992
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283 · DYH
Jeneric/Pentron, Inc.
Dental · 281d
Cleared Dec 23, 1992
INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK
K921632 · HQZ
Lawrence Technologies, Inc.
Ophthalmic · 261d
Cleared Dec 23, 1992
LEAPLAZA FRAME
K922238 · KWP
Spintech, Inc.
Orthopedic · 224d
Cleared Dec 23, 1992
LORENZ 1.0 MM SYSTEM
K922741 · JEY
Walter Lorenz Surgical, Inc.
Dental · 198d